Intensive Preventative Dental Program Pilot Study

Early Phase 1CompletedNCT07218068

Wake Forest University Health Sciences13 enrolled

Overview

Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.

The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dental Diseases

Interventions

Fluoride varnishDRUG

fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart

Regular CareOTHER

standard oncology assessment visit without Intensive Preventative Dental Program services

Medical Oncology Care TeamOTHER

Medical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 years and older * Willing and able to provide signed and dated consent form * Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management * Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy; OR * Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites: 1. base of tongue 2. buccal/labial mucosa 3. epiglottis 4. floor of mouth 5. gingiva/alveolar ridge 6. hard palate 7. hypopharynx 8. larynx 9. lip 10. mandible 11. maxilla 12. maxillary sinus 13. nasal cavity 14. nasopharynx 15. neck 16. oral cavity 17. oral tongue 18. oropharynx 19. paranasal sinus/orbit 20. parotid gland 21. pharynx 22. retromolar trigone 23. soft palate 24. sublingual gland 25. submandibular gland 26. tonsil; * Willing to comply with all study procedures * Willing to participate for the duration of the study * RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites. Exclusion Criteria: * Receiving palliative RT * History of prior curative RT to the head and neck region to eradicate a malignancy. * Incarcerated at the time of screening * Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change in Decayed, Missing and Filled Surfaces Score

Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.